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Incorporates

Regulatory Information Management & IDMP Solutions Solutions

IDMP Readiness Assessment

Conducting a Readiness Assessment – the PAREXEL Way

The first step to achieving IDMP compliance is assessing where you are today. Until now, biopharmaceutical companies have known they face a complex and daunting task, identifying and collecting data from multiple sources and systems, extracting it from documents, codifying that data to meet the standards, then developing solid long term processes for data updates and maintenance. A readiness assessment makes it clear to an organization that IDMP is not just the responsibility of Regulatory, but the entire enterprise.

At PAREXEL, our readiness assessments provide an overview of your existing data environment and the supporting processes both centrally and across regions. It will indicate what data is available in which format (electronic or paper), where there are data discrepancies or missing data, as well as who has data accountability. As part of the assessment, as-is processes are mapped so that effective to-be processes can be defined for process changes that are needed. It will help you to identify and prioritize problem areas so that a solid road map can be created to bridge gaps and ultimately maintain a high quality, long term, and very valuable corporate asset.

In summary, a readiness assessment will allow you to:

Determine what programs already exist for data stewardship and governance

Identify the processes needed for resolving data issues and maintaining long term data quality and data integrity

Enable business and systems owners across the enterprise to make decisions around who owns data today and who will own it in the future

Who needs to be involved in the PAREXEL readiness assessment process? Typically, subject matter experts across the effected departments, those in charge of existing governance mechanisms, and systems/data stewards of the various source systems to be analyzed. This group will work together with PAREXEL to identify a framework for assessing your organization’s data and process readiness for a global IDMP program.

Questions to answer during a PAREXEL readiness assessment include:

Is the data available electronically? Or on paper? Or non-existent?

Is the data complete?

Is the data in the correct format?

Who are the current data owners?

Does the data comply with vocabularies that are available today?

What is the current state of your supporting processes and where is process enhancement needed?